UMIN-CTR Clinical Trial

Basic information
Public title	Physical and mental effects of foot-bath among women in labor
Acronym	The effects of foot-bath among women in labor
Scientific Title	Physical and mental effects of foot-bath among women in labor: A pre-post-test experimental design
Scientific Title:Acronym	The effects of foot-bath among women in labor: A pre-post-test experimental design
Region	Japan

Condition
Condition	Women in labor
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the physical and mental effects of foot-bath using biomarker and self-administered questionnaire.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The salivary cortisol levels immediately after foot-bath
Key secondary outcomes	The levels of relaxation, comfort, labor pain, warmth of body, vital signs, and interval of labor pain immediately after foot-bath

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	For women in the first stage of labor, implement a foot-bath for 15 to 20 minutes using a foot-bath machine. The temperature of the hot water should be in the range of 38 to 42 degree Celsius, which is set to a temperature that the women feels comfortable with. During the foot-bath, do not apply any stimuli such as pushing the acupoints or massaging.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Women in the first stage of labor or induction of labor.
Key exclusion criteria	Women who can not answer the questionnaire of have difficulty participating in the study.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Akemi Middle name Last name Isoyama
Organization	Dokkyo Medical University
Division name	Graduate Program of Midwifery
Zip code	321-0293
Address	880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi
TEL	0282-86-1111
Email	a-isoyama@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name Hikita
Organization	Dokkyo Medical University
Division name	Graduate Program of Midwifery
Zip code	321-0293
Address	880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi
TEL	0282-86-1111
Homepage URL
Email	nhikita-tky@umin.ac.jp

Sponsor
Institute	Dokkyo Medical University
Institute
Department

Funding Source
Organization	Dokkyo Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Dokkyo Medical University
Address	880 Kitakobayashi, Mibu, Shimotsuga-gun, Tochigi
Tel	0282-86-1111
Email	soumu@dokkyomed.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2021 Year 11 Month 22 Day
Date of IRB	2021 Year 11 Month 22 Day
Anticipated trial start date	2022 Year 01 Month 17 Day
Last follow-up date	2022 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 01 Month 05 Day
Last modified on	2022 Year 01 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053088

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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